Posted in Science and Research
Job Description
Job Purpose
The STS Quality Specialist II will provide support for Document Control and Technical Writing; this position will support the Quality Management System for the Science and Technology Team facility in San Diego, CA.
Job Duties, Responsibilities and Authorities
The role has the following responsibilities and authorities as assigned by the Manager:
Responsible for efficiently processing Document Change Requests (DCRs), including routine data entry, coordinating document review/approval/release per department SOPs.
Use MasterControl to manage all document reviews and workflows.
Responsible for document writing and revision processes to be progressed in a timely manner by all parties; this requires strong communication, follow up and influencing skills.
Provide Technical Writing support through conducting Document Reviews and use practical laboratory scientific work experience and Technical Writing skills to revise technical SOPs; this requires strong time management, prioritization, and interpersonal skills to coordinate cross-functionally with scientists and Principal Investigators as well as excellent listening, interpreting, and writing skills.
Assist with revisions to Quality, Operations and EHS SOPs as needed. Assign Master Control job codes and training correctly. Participate in Internal Audits, and as an Internal Auditor. Support Quality Management System and Quality Department with other responsibilities as assigned.
Education & Experience
Bachelor's degree is highly preferred, Associate/High School and/or combination of education and experience may be considered.
At least 2 years of scientific laboratory and/or manufacturing work experience required.
Prior work with document control in a GMP manufacturing environment is preferred.
Knowledge, Skills, Abilities
Experience with Master Control is preferred.
Experience managing Document Control system is preferred.
Technical and laboratory work experience is required.
Strong understanding of ISO 9001:2015 standard is required.
Work independently with minimal supervision and direction.
Ability to influence others and work cross-functionally.
Promote safe work habits and adheres to safety procedures and guidelines.
Strong planning, organization and multitasking skills.
Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
Able to provide effective written or verbal communication to peers, senior associates, and area management within their operational groups.
Compensation and Benefits
The salary range estimated for this position based in California is $66,000.00-$99,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
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